63Moreover, the notion of a global marketing authorisation referred to in the second subparagraph of Article 6(1) of Directive 2001/83, as amended, follows the line of well-established case-law of the Court of Justice (see paragraph 45 above), which developed that notion in particular to take account of the objective of the ‘abridged’ procedure, which is to save the time and expense needed to gather the results of the pharmacological and toxicological tests and clinical trials, and to avoid the repetition of tests on humans or animals (see judgment of 16 October 2003 in AstraZeneca, C‑223/01, ECR, EU:C:2003:546, paragraph 52). That objective would clearly be jeopardised if the producer of the original medicinal product were able to extend indefinitely the regulatory period of data protection and thus prevent producers of generic medicinal products from using that product as a reference product when the regulatory data protection period expressly provided for by the legislature in order to reconcile the interests of innovative undertakings and the general interest expired.
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